Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01431170
First received: September 6, 2011
Last updated: June 15, 2016
Last verified: March 2016
  Purpose
The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The hypothesis of the study is that Besivance™ is as safe and effective as the current standard of care for the treatment of nasolacrimal duct obstruction in children.

Condition Intervention Phase
Congenital Nasolacrimal Duct Obstruction
Drug: Besivance Treatment Group
Drug: Polytrim Treatment Group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blinded, Parallel-Group, Randomized Study to Assess the Safety and Efficacy of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier. [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

    The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:

    • 0: No tearing and discharge.
    • 1: Tearing, moderate mucous discharge around nasolacrimal punctum
    • 2: Moderate redness of the medial eyelid with mucous discharge
    • 3: Redness and swelling of the eyelid with mucopurulent discharge
    • 4: Redness and swelling of eyelid with purulent discharge

    Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following:

    Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit.

    Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit.

    Treatment Failure: grade is worse than or same as the baseline visit.



Secondary Outcome Measures:
  • Number of Recurrences by Randomization Group [ Time Frame: Baseline to Week 16 (Closeout Visit ) ] [ Designated as safety issue: No ]

    Recurrence is defined as when the NLDO with infection in the subject's study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit.

    Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group.


  • Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO [ Time Frame: Baseline to Week 16 (Closeout Visit) ] [ Designated as safety issue: No ]
    Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as "Treatment Success" or "Treatment Failure" according to study protocol.

  • Treatment Failure [ Time Frame: Baseline to the time of failure or Week 16 (Closeout Visit) ] [ Designated as safety issue: Yes ]

    Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.

    Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care.


  • Medication Safety Outcomes [ Time Frame: Baseline to Week 16 (Closeout Visit ) ] [ Designated as safety issue: Yes ]
    During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.


Enrollment: 24
Study Start Date: September 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Besivance Treatment Group
Besivance™ ophthalmic suspension, 0.6%
Drug: Besivance Treatment Group
Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Other Name: Besifloxacin,Besivance
Active Comparator: Polytrim Treatment Group
Polytrim ophthalmic solution
Drug: Polytrim Treatment Group
Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Other Name: polymyxin b/trimethoprim - ophthalmic

Detailed Description:
The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.
  Eligibility

Ages Eligible for Study:   1 Month to 12 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons who have been diagnosed with congenital Nasolacrimal Duct Obstruction (NLDO) with infection by the Principal Investigator
  • Both males and females
  • Persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is defined as when the Principal Investigator makes clinical diagnosis.)

Exclusion Criteria:

  • Persons who have received any antibiotic treatment for NLDO with infection for more than 2 week in the past 4 weeks.
  • Persons who are currently receiving systemic antibiotic treatment that cannot be discontinued.
  • Persons with any other ocular anomalies that could potentially interfere with interpretation of study results.
  • Persons who have had any prior nasolacrimal duct system procedures such as stenting or probing.
  • Persons who have previously participated in any clinical trial(s) of Besivance™
  • Persons who have participated in any other clinical trial(s) of any investigational agent(s) within 30 days prior to the Baseline visit
  • Persons who have any chronic diseases that might interfere with study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431170

Locations
United States, New Jersey
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Suqin Guo, M.D. Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01431170     History of Changes
Other Study ID Numbers: 0120110184 
Study First Received: September 6, 2011
Results First Received: December 23, 2015
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ophthalmic Solutions
Trimethoprim
Fluoroquinolones
Polymyxin B
7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
Pharmaceutical Solutions
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016